Welcome, everyone, to the 43rd Annual J.P. Morgan Healthcare Conference. My name is Tessa Romero, and I'm one of the Senior Biotech Analysts here at J.P. Morgan. We're pleased to welcome to the stage Acadia Pharmaceuticals, and presenting on behalf of the company, we have CEO Catherine Owen Adams. Catherine, over to you.
Good morning, ladies and gentlemen. It's a pleasure to stand here as the new CEO of Acadia Pharmaceuticals. Officially enrolled just over 100 days, so I guess that means it's not actually new anymore, but I'm excited to be here this morning to share more about our vision for Acadia . I come into this role with over 30 years of pharmaceutical experience, most recently as the Senior Vice President and General Manager of the U.S. at Bristol Myers Squibb, and prior to that, leading the international markets business in Europe, Japan, and Canada, where I oversaw nine launches in the last five years in rare disease and other therapy areas. Prior to that, I had 25 years' experience at Johnson & Johnson, working in various parts of their business, mainly in pharma, but a quick swing into med tech at some point as well.
I had roles in R&D, mainly commercial, and my most recent roles at J&J were President of the HIV and Vaccines business and then President of the Immunology business. So why did I choose Acadia ? That's the question I get most often from our analyst friends, but I think there's three main reasons why I chose to come to Acadia . The first is a really strong commercial business that I'm going to share more about today. That was important for me as a platform to apply my capabilities immediately. The second was an exciting pipeline, which I'm going to share more about today, and I continue to be really excited about the potential that that has for patients, particularly in areas of higher unmet medical need, and the third reason was joining a company with a really strong financial foundation.
And we'll share today a little bit more about that as we move forward into our presentation. So I see significant opportunity to enhance shareholder value this year and beyond. And this presentation, I hope, will share some of that vision with you. I'm going to be making forward-looking statements, so I direct you to our recent SEC filings, where you'll see descriptions and risks and uncertainties relevant to our business. So today, we've just announced a number of exciting opportunities for this year. I just want to talk about some of the highlights of that press release. So 2025 will be the first year in Acadia 's history that we hit over $1 billion in net sales, a very exciting milestone for us to cross. We also announced this morning the filing of our marketing authorization application for DAYBUE in Europe.
And we're expecting that we could receive EU approval as early as Q1 2026 for DAYBUE. We're also pleased to share today some milestones for our late-stage programs in Prader-Willi and in Alzheimer's disease psychosis, and I'll go into some of those details in a minute. And we're excited to announce this morning a second phase two study for ACP-204 in Lewy body dementia with psychosis. We're also pleased to announce our first ever R&D day, which we will be holding in mid-2025 under the direction of Dr. Liz Thompson and her team, we'll be unveiling more about our pipeline. So taken in totality, along with a very strong and positive cash flow, it gives me a real sense of excitement about the future of Acadia . Just to give more clarity to some of those timelines, this is laying out 2025 and 2026 more specifically.
So with DAYBUE, we've just filed our MAA for Europe. We are also making available DAYBUE through a managed access program in Europe in select countries. And that will actually generate our first ex-U.S. revenue in 2025 and looking to get that approval in Europe in Q1 2026. In terms of ACP-101, our Prader-Willi program, we're expecting to have phase III fully enrolled by the end of this year. This is a global program and seeing top-line results in early 2026. In terms of ACP-204, we will continue to recruit our phase 2 program in Alzheimer's disease psychosis this year, initiate our Lewy body psychosis trial, and hope to see top-line results from the ADP trial in the first half of 2026. Finally, as I've already said, we'll have our R&D day, and we will hit $1 billion in annual revenue.
In terms of our overall growth strategy and driving shareholder value as we move forward with Acadia , we just wanted to share strategically where we see that evolving over the next few years. I'm going to share more today about our two commercial franchises in Neuropsych for NUPLAZID and in NeuroRare for DAYBUE. We're going to share more specifics around the ACP-204 core pipeline development program. But we're excited in Q4 of last year to license in a product for essential tremor, ACP-711, which is a selective GABA alpha-3 modulator. I'm gonna share more about that as well as we move forward. And we're also looking at ACP-211, which is an NMDA receptor antagonist, looking at that in TRD and MDD and actually other indications. In terms of our rare disease pipeline, we obviously have DAYBUE, which we look forward to growing and expanding globally this year.
We have our PWS trial in Prader-Willi syndrome, which we just said is going to fully enroll during 2025. But we also have ACP-2591, an exciting program that we're looking at in Rett and Fragile X. And we have now a focus on BD with our very strong cash flow and balance sheet in terms of expanding our pipeline, both in NeuroRare, but also in adjacencies. And we're looking specifically at some of the areas that you see on the slide here. So overall, we're really excited about the possibilities of enriching our pipeline and moving forward in terms of our more near-term development programs. So I'm now going to take the opportunity to dive more deeply into some of these areas and give you some more specific details.
In terms of the neuropsychiatric franchise, we launched last year a really interesting awareness program in partnership with Ryan Reynolds and his mother, Tammy. And this was to really stress and make aware caregivers and their families that Parkinson's disease is more than a cluster of motor symptoms. The awareness in our caregiver population is relatively low that psychosis in terms of hallucinations and delusions can be part of this disease progression. And so we partnered with Ryan and his mom, Tammy, because Ryan's dad was actually afflicted by this terrible disease. And Ryan has been sharing his story on various channels, omni-channel, multimedia. And I thought it would be nice for you to hear a little bit from Ryan today in his own words. So hopefully the video will now play.
It wasn't until very late into my father's battle that I even knew hallucinations and delusions were common in people with Parkinson's. I hope people at some point understand that there's help available for this specific thing. This is why I'm very proud to partner with Acadia Pharmaceuticals to raise awareness of Parkinson's-related hallucinations and delusions, which are a common, yet pretty often overlooked aspect of Parkinson's.
As you can see, Ryan has made a big impact to the awareness of hallucinations and delusions. And we are working with him as we move into this year to continue that awareness campaign because there are one million people affected by Parkinson's in the U.S., and about 50% of those will develop hallucinations and delusions at some point during their disease progression. As I've said, there's very low awareness of these symptoms among caregivers. And so that's why it's so important that we're investing in these awareness campaigns to raise that awareness and encourage patients to come in and talk to their doctors about the possibilities of treating with NUPLAZID, the only approved medication for Parkinson's disease, hallucinations, and delusions. Since we launched this product, we have treated over 82,000 patients in the U.S.
It's the most studied drug in Parkinson's disease psychosis and continues to show no negative impact on motor function. We have a compelling real-world evidence generation program, which continues to read out, we're gonna be sharing our five-year data this year. In terms of the impact on net trade sales, we saw a 10% year-to-date net sales growth last year up until Q3. We're not going to be reporting Q4 until our call in February, but I can tell you that we've seen a real increase in referrals during Q4, probably as a result of the awareness campaign with Ryan, but also with that, our branded DTC campaign. We believe there's a lot of room to grow NUPLAZID. We're investing to grow NUPLAZID, and we're excited to bring this treatment to more patients as we move through this year.
We have ongoing litigation with our patents, but we remain confident in our composition of matter patent, which goes out to October 2030, and our formulation patent, which goes out to February 2038. So in terms of our focus this year, we are investing to drive NUPLAZID growth. We're gonna continue to activate consumers and drive their interest in terms of pull-through, and we're already seeing them come into the doctor's offices asking to learn more about NUPLAZID. We think there's a huge potential to drive our market share. As I've said, we're only 20% penetrated right now. The other 80% of patients are treated with off-label antipsychotics. Our real-world evidence shows that we have a significant mortality benefit with NUPLAZID against these off-label antipsychotics, a reduction of 22% in mortality. I hope you understand that's truly significant for patients and their caregivers.
And we're going to be driving against additional publications for this data set as we move forward this year. We're also investing in AI technology to maximize the efficiency and the effectiveness of our field force. And you'll see that both in DAYBUE and NUPLAZID as we move forward. So in terms of DAYBUE, our second core commercial franchise in the area of rare disease and more specifically with DAYBUE Rett syndrome. As you may or may not know, Rett syndrome is a devastating, highly debilitating disease. These girls, it affects girls mainly, are born normal. They develop normally until the age of about two, between 18 months and two, where their families start to see plateauing of progression, and then they start to see regression, specifically in terms of motor impairment, loss of communication skills, the start of seizures, until eventually these children need 24-hour care around the clock.
These are true warrior families that we've gotten to know through the launch of DAYBUE. And they, they really are an amazing set of patients and an amazing community that we seek to continue to serve. There are about 5,500 patients diagnosed with Rett in the US right now. And as is common with the launch of rare disease products specifically, we've actually seen an increase in the specific diagnosis of Rett disease since we've launched DAYBUE at about 20%. In terms of the population that we seek to serve in Europe, that's about 9,000-12,000 patients. So again, a larger population in Europe where we hope to bring DAYBUE in early 2026. So since the launch of DAYBUE in the U.S. in April 2023, we've served over 1,600 patients and their families.
And we're excited to see that once the patients have got through the first few months of titrating the dose and understanding the GI side effects that specifically affect their loved one, we're seeing a really strong patient base and persistency. What we're seeing right now at 10 months is over 66% of patients still on therapy, and that's continuing to hold at 12 months and beyond. So we're really seeing the impact that DAYBUE has on patients in terms of changes in motor function, changes in communication skills abilities, and really seeing those effects continue to compound over time. And we're observing that in our LOTUS real-world evidence study, which we continue to publish data on. So we're also really concentrated on access for DAYBUE . It's obviously important that our patients have the ability to access the product.
And we're proud to say that 90% of patients who access DAYBUE in the U.S. do so at less than $10 per month. In terms of the outlook for 2025, we are going to be continuing to drive the clinical experience that we're seeing with DAYBUE and increasing the awareness of our evidence and our data through omni-channel strategies, which we're going to be trying to bring the DAYBUE data to life a little bit more. We're gonna be using much more video vignettes to help people understand the impact that this drug can have on their loved one. We're also, with the new leadership of our CCO, Tom Garner, going to be increasing our field force by 30%. We believe that's necessary this year to drive our ambition to get back to growth in new patient starts.
We're going to be increasing their ability to contact physicians who treat patients with Rett outside of COEs or centers of excellence. We know that 70% of patients are actually treated outside centers of excellence, so it's important for us to have reach and frequency against those physicians specifically. That additional field force will also involve an increase in our family access manager group, who specifically work with patients during their initial stages of therapy to ensure that they understand how to use the product and they're informed about managing the GI side effects, so a real strong investment into DAYBUE again this year, also looking to seek to launch a direct-to-consumer campaign, which I've experienced in prior lives in terms of rare disease, and though it's very important to ensure we're able to communicate the efficacy and safety messages of DAYBUE directly to those families and caregivers.
As I've already said, we're pursuing our license outside of the U.S. in terms of the European Union. But beyond that, we're looking to ensure that patients have access to DAYBUE in Japan. We're continuing to discuss with the PMDA and hope to start a local trial in Japan by Q3 of 2025. Our primary goal this year is to return DAYBUE to growth. And I believe with these investment strategies, we will absolutely see that happen. So I'd now like to turn to our pipeline and give you a little bit more detail about the programs that we have right now, but also some of the programs we'll see elaborated upon at our R&D day that we're holding mid-year this year.
You can see on this slide 12 programs that we currently have underway at various stages of development, both in our CNS franchise, but also our rare disease franchise, and a couple of products that kind of cross over between the two and have the ability to possibly work in both areas of the business. I'm actually going to deep dive now into three specific programs here and understand that Liz and team will be elaborating more across the other programs when we get together mid-year for our R&D day. The first area I'd like to focus us on is the ACP-101 trial in Prader-Willi syndrome. So Prader-Willi syndrome is a genetic disorder caused by a mutation on chromosome 15. These babies are born with very low muscle tone. They're diagnosed very early after they're born. So it's a very specific and quick genetic diagnosis.
It's a complex set of neurobehavioral diseases, but it's most often dominated by the disease or by the symptom that's very well known, which is hyperphagia, an uncharacteristic relentless hunger, where the patients have an impaired neural response to food intake and an inability to regulate their food intake in response to their energy needs. As a result of that, these patients unfortunately become obese over time, giving a life expectancy of 30 years for these patients. So there's true unmet medical need in this space, and it's an area that's affecting about 8,000-10,000 patients in the U.S. right now. ACP-101 is an intranasal carbetocin, a long-acting analog of human oxytocin, which selectively binds, actually more than oxytocin itself, to the oxytocin receptor. We're developing it to be delivered intranasally, so it will be a drug-device combination.
And the program is currently in clinical trial in a phase three global study, double-blind, placebo-controlled. It's a 12-week study, and we're using the 3.2 milligram dose, which was previously observed to have a direct effect on hyperphagia-related behaviors in a previous clinical trial. As we've said, we're excited to get this program fully enrolled this year with our opportunity to see top-line results early in 2026. So we're really excited for this program. To remind you, it has orphan drug designation, fast-track designation, and rare pediatric disease designation by the FDA. So we're excited to develop this drug for a possible solution in an area of really high unmet medical need. As we move into ACP-204, I'm going to be describing both of our development programs today in both Alzheimer's disease psychosis and also our newest focus in Lewy body dementia.
So Alzheimer's disease psychosis, probably everybody here understands Alzheimer's disease, unfortunately. But along with that, about 30% of patients develop Alzheimer's disease psychosis as the disease progresses. I experienced this firsthand. Both my parents have Alzheimer's disease. My mother suffers from psychosis. Currently, she believes she's a drug dealer. And while it's kind of funny, it's also completely devastating for the families. She's currently prescribed off-label antipsychotics. She's sedated. And there's a huge area of unmet medical need here to have a truly well-designed product to treat these disease to treat these symptoms much more specifically. And that's what we're aiming to do with ACP-204. ACP-204 is a new 5-HT2A inverse agonist that's been designed specifically, understanding pimavanserin, and trying to ensure that we build upon that and enhance the efficacy. There's really three main areas that we've looked to enhance in terms of the action of ACP-204.
The first is to mitigate or eliminate the QT prolongation signal that we do see with pimavanserin. The second is to enable higher doses of ACP-204 to be given to patients, and the third was to improve time of onset of action. We've now treated over 200 patients in phase I clinical trial programs, the first of which we started to publish, and you'll see further publications this year, and what we're seeing so far is that we're living into all three of these ambitions, and we're excited to see how we continue to progress through our phase two clinical trials. Our RADIANT study is a unique designed phase two, phase three study. It's a global double-blind placebo-controlled study that actually has a treatment arm for six weeks and then seamless enrollment into a phase three study.
So basically, once the center has completed their enrollment for phase 2, they can start enrolling phase 3 patients. Why is this important? Because it will hopefully give us an accelerated timeline to complete the enrollment of our phase 3 study as we move forward. So looking ahead, we hope to have this study enrolled by the Q1 of 2026 and see those top-line results by the middle of next year. Today, we announced a focus of ACP-204 in Lewy body dementia. Lewy body dementia is a disease associated with abnormal deposits of a protein called alpha-synuclein in the brain. These Lewy bodies affect the brain in terms of changes to thinking, movement, behavior, and mood. And Lewy body dementia is one of the most common causes of dementia, with over a million people affected by it in the U.S. alone.
Again, 50%-75% of these patients with Lewy body dementia will suffer from a kind of psychosis, specified by hallucinations and delusions, and these are the patients we're hoping to treat with ACP-204. Currently, about 200,000 of these patients are prescribed off-label products to treat the symptoms, and again, we're hoping to ensure that we have a well-designed, well-controlled product to bring to these patients specifically to treat these symptoms. The study we're looking to initiate will be a phase II study, and we are looking to recruit patients using a focus on biomarkers as well as symptomatology, so we're going to be adding a biomarker element into our clinical trials.
We arrived at the decision to move forward in the direction of Lewy body dementia based in part on data that we saw in a previous pimavanserin study, which did show a suggested potential of improvement in patients targeting the 5-HT2A specifically, so we're excited to get this underway this year, and then finally, in terms of the pipeline, I wanted to share a little bit more about our recent acquisition from Saniona, which is now renamed ACP-711 or ACP-711. We signed the deal in Q4 of last year and a great example of Acadia using our strong balance sheet to bring external innovation into the company to enhance our pipeline, so why Essential Tremor? As I said initially, our strategy is to develop Acadia products that can be either first-in-class or best-in-class, and we believe this is absolutely possible for ACP-711.
Essential tremor is the shaking and uncontrollable movements, mainly in the upper body, hands, difficulty using the hands, a shaky voice, a nodding head, and it gets worse and progresses over time. Unfortunately, this can lead to significant social avoidance, very reduced quality of life, and right now, the only products available to treat essential tremor were approved over 50 years ago and in the form of a beta blocker, which work in less than 50% of patients, so again, a true unmet medical need, which we believe we can serve with ACP-711. In terms of the product and why we found it exciting, it's a very selective GABA alpha-3 positive allosteric modulator, so Liz does a better job with this.
But what we do know is that GABA is involved in essential tremor, and most specifically the alpha-3 subunit, which we know is expressed in key regions of the brain associated with motor function. And what we saw with the ACP-711 is a high affinity for the alpha-3 subunit and a relatively low or no affinity for alpha-1, alpha-2, and alpha-5. And why that's important is those particular subunits are more commonly associated with side effects, sedation, and cognitive impairment. So with this highly specific GABA alpha-positive allosteric modulator, we believe we have the potential to treat tremor without driving those unwanted side effects. The phase II trial is planning to start in 2026.
And in 2025, we're gonna be enhancing our focus on the phase one stage of this development to start a cohort in the elderly to ensure that we get data that informs the right phase II and phase III clinical trial design, enhancing our commitment to ensure that the patient voice and patient understanding is driven very early into our pipeline development. So in closing, I have appreciated the opportunity to share our plans on behalf of Acadia, our management team, and fellow Acadians who are working all around the world right now to drive this pipeline for our patients. Just to close, we believe much more is possible with Acadia. We're proud to have two core franchises with strong growth this year to deliver over $1 billion in cash flow, and we look forward to expanding DAYBUE into Europe and beyond.
From an R&D perspective, we're building a deep and diverse pipeline, and we look forward to sharing the results of our late-stage programs towards the beginning of next year. And financially, we're in a very strong cash position. We have over $700 million on the cash flow, and we're reinvesting to fuel that growth in our future by making specific and focused BD investment decisions. So to join me in the Q&A, I'd like to introduce our management team, our new CCO, Tom Garner, our CFO, Mark Schneyer, and our head of R&D, Dr. Liz Thompson. And with that, we'll open it for questions.
Great. Thank you, Catherine. Can you talk a little bit more about the key drivers that underpin that more than $1 billion run rate that you're talking about for 2025?
Yeah, so that's obviously driven by the two commercial brands.
And as I've already said, we're seeing very strong growth in NUPLAZID, and we expect that to continue and accelerate into 2025. And that's underpinned by our focus on driving the commercial footprint and the DTC campaigns. And in terms of DAYBUE, we are going to return that brand to growth in terms of new patient starts and see the initial revenues coming in from Europe. So that's really where we're getting that total from.
And just to follow up on this, can you talk a little bit about kind of any kind of cadence or timing of growth, how to think about quarter over quarter given the efforts that you just kind of laid out, including expanding your sales force, DTC for DAYBUE?
Yeah, Tom, would you like to talk to that?
Sure. Can I use yours?
So we are going through the process of the change that Catherine mentioned in terms of DAYBUE field structure as it stands at the moment. And our goal would be to have this operationally in place in Q2. So I think as you think about your question about cadence, it's more likely to be Q3 onwards that we begin to see the impact of the field force changes. However you know, as Catherine mentioned, we're also amplifying our DTC efforts. In fact, our DAYBUE YouTube channel actually went live this morning, which has a number of case vignettes that are directly helping patients understand what they can expect to see with DAYBUE, how does this fit within my individual journey as a rare caregiver. So those efforts are being amplified already, and we will be launching additional campaign updates through the second half of the year in addition to that.
Thanks, Tom.
Another big picture question for me. Can you talk a little bit about how you think about capital deployment and balancing internal priorities like your R&D versus external BD for 2025? I know you were just acquisitive with another asset, so.
I can, but I think our CFO would probably like to talk to that more than I would. Mark.
Yeah, sure. I would characterize it as it's an and not an or. I think we have a very strong balance sheet, no debt, ability to invest in the business or commercial franchises, our pipeline, and enhance the portfolio through business development. So I think at this point, we're in a very fortunate position where we're not making trade-offs of what we can and can't do. It's really what can we do to deliver value to the company, patients, and shareholders by investing across all those areas.
And I'm sure you're gonna provide 2025 expense guidance in February, but can you give us any kind of color at this time?
I think what we'll say is we're going to continue to invest to grow our commercial brands, and we'll give you more specifics at our February call.
What factors do you think limited some of the growth of DAYBUE in 2024?
You know, I think based on my experience in other rare launches, it's not an unexpected phenomenon that we saw with DAYBUE, which is a huge unmet medical need when you launch something into a space where there's been nothing. And we saw that very clearly with DAYBUE, very strong out the gates. And the Centers of Excellence really adopted the brand very quickly. As I've already said, the dynamic is that about 70% of patients are not treated in the Centers of Excellence.
And so what we saw sort of Q2 almost last year was a flattening in terms of the new patient starts. And we also saw the impact of trying to understand how to manage the GI side effects of DAYBUE, specifically in every different patient. It's a different journey. And we learned a lot about how to manage that in the field. And as we came into the Q4 last year, we put in place a number of different programs to ensure that we're now managing those first few months a little bit more closely and learning the lessons that we've had over the last year, so we have had a plateauing of new patients in the last couple of quarters.
And as I've said already, as we're putting in place these new strategies that Tom has just outlined, I feel very strongly that we can turn this brand back to growth in terms of new patient starts and, really importantly, build upon our strong, stable, persistent patient base, which continues to grow. And the importance of that is that patients are seeing efficacy not only at the start, but they're seeing efficacy compound and improve over time. And that's being captured in our real-world evidence studies. As with all good brands, you continue to publish evidence as you move forward. And I think our evidence will remain compelling and be another reason why patients will continue and their families will continue to look at DAYBUE and look to start.
And finally, we have more than 65% of patients who have not tried DAYBUE yet in the U.S., and so that there's a lot of potential to grow the brand in the U.S. and beyond.
Can you talk a little bit more about how you're going to activate those non-prescribers?
Yeah, I can, but I think Tom would probably like to do that.
Of course. I think, as Catherine mentioned earlier on in the presentation, if we look at kind of our total prescriber universe for DAYBUE, in the U.S., it's around 5,000 HCPs who at some point will touch a Rett patient. Now, with the focus and the field structure that we have today, unfortunately, we've been relatively narrow in the number of people that we can really treat outside of the COE.
So just for those folks who aren't aware, you know for reps, you have kind of at the core, the Centers of Excellence. Then we have what we call COE-like accounts. And then beyond that, we have just kind of general HCPs who may well touch the patient on their journey. So simplistically put, what we're aiming to achieve with the expanded field model is we will increase the number of shots on goal that we have to have a direct conversation with any of those HCPs who could be touching the Rett patient or their caregiver on their journey. So we're trying to make sure that we, A, increase the kind of surround sound that exists for DAYBUE in totality, but at the same time, make sure that we're meeting the HCP and the caregiver at the appropriate point in their treatment journey as well.
How do you drive titration strategies to optimize treatment outcomes? I know that was a theme at the AES conference in December.
Yeah, so what we're seeing is that every physician is approaching it slightly differently, and the Centers of Excellence will have their own specific approaches. What we're trying to do is actually bring that together in a publication to share with the broader audience to show the different strategies that HCPs employ. Some start at the absolute recommended dose and then titrate according to symptoms. Some start now at a lower dose and titrate up. And what we're trying to do is bring all that medical evidence together in one place so that families and physicians can have a more informed approach to their specific loved one.
And I was hoping to segue here and ask about your pipeline, which I think is on display in this presentation here. How do you think about diversifying risk? Where are you most excited from you know a reward perspective? What's lowest risk in your view? Maybe more high risk, high reward? How do you think about that?
So I think in terms of diversifying risk, it's important to sort of think through what are you trying to diversify? What risk are you really talking about? And so obviously, in any clinical trial setting, there's risk. But what we're trying to do right now is think about areas of higher medical need where we would have a first-in-class or best-in-class product. And we have a strong conviction in the clinical profile of the product as we bring it in.
And we have a strong conviction in our R&D capabilities to take it from where it is to commercial and that we have a strong commercial capability to get that drug to market. So for me, risk is about that whole, that whole from the lab to commercial and ensuring that we feel really strongly that Acadia is the right place to bring that product in. We feel really strongly that we can take it to patients on our own or in partnership. So that's how we're thinking about it. We're also thinking about higher areas of medical need which still have a relatively low number of approved drugs. I think essential tremor is one of the more classic spaces. Liz, do you want to talk about the risk that you see?
I think, of course, Catherine articulated it very well.
We are more interested in taking risk on, let's call it a scientific or a technical perspective, than taking the risk of being the seventh also-ran in a very crowded area where we don't have clinical differentiation. So I'd say that first and foremost, those are the areas where we're more interested in pushing into un un unmet need spaces or spaces where you know we're the first bringing forward a new mechanism, for example. As I look across our pipeline, what I like in the pipeline that we've built to date and that we're going to continue to do is that there's always a clear scientific hypothesis of why we think that something could work. Obviously, different scientific hypotheses there have different amounts of data currently supporting them.
For example, you'll see in some of the things we're doing with 204, we're starting us on a firm foundation of data that we get out of the pimavanserin program that's then hopefully going to be augmented by what we see as clear improvements with 204 versus pimavanserin. S o we're trying to be mindful about making sure that we're concentrating risk in the areas that we're most interested in taking it, making sure we're bringing real innovation forward, at least have the possibility, but then always trying to be really disciplined with the fact that we've got a clear hypothesis with as much data underpinning it as possible.
I think from a commercial point of view, I mean, I think Catherine made the case today, and you can see it on the slide in front of you know.
All of these opportunities, A, I mean, they are kind of white spaces as we think about them commercially. But you just think about kind of the evolving group of patients that we would be treating with each of these. I mean, these are you know relatively untapped. I think if you just take ADP as an example, as Catherine mentioned, you know these patients are being treated, but they're being treated with substandard off-label drugs. And I think if you bring new treatments with good scientific foundation that really kind of treat the underlying cause of disease, we will have a very compelling value proposition for patients, for HCPs, and for payers, which is obviously going to be critically important as we move forward.
I think we might have to leave it there. Thank you so much to the entire Acadia team, and thanks everyone for joining.